Dynavax Technologies

Biostatistician (Senior)

US-CA-Berkeley
1 month ago(12/12/2017 2:59 PM)
ID
17-064N
Category
Clinical

Overview

This position is responsible for the design, development, modification and evaluation of a technical infrastructure to expedite conduct and evaluation of clinical trials and basic research.  Duties will include but not be limited to collaborating with project team to determine protocol design and develop statistical analysis plan; working with clinical data manager and clinical team to ensure quality data collection; interacting with statistical programmers to develop specification documents for creating CDISK-conforming analysis datasets and statistical outputs including summary tables, listings and figures; ensures appropriateness and accuracy of statistical outputs to support the development of clinical study reports, regulatory submissions, presentations and  publications;  and performing statistical analysis and research as necessary.

Responsibilities

  • Provides statistical inputs on trial design and study endpoints, determines sample sizes, develops and authors statistical analysis plans.
  • Utilizes knowledge of regulatory requirements and guidance documents to provide statistical advice with respect to creating a clinical development program.
  • Collaborates with clinical team to ensure quality data collection.
  • Interacts with statistical programmers to develop specification documents for creating CDISC-conforming analysis datasets and statistical outputs including summary tables, listings and figures.
  • Ensures appropriateness, adequacy and accuracy of statistical outputs to support the development of clinical study reports, regulatory submissions, presentations and publications.
  • Conducts statistical research as necessary to keep up with methodology advances and performs statistical analyses and/or simulations to address specific study needs.
  • Plans, prioritizes and tracks activities across projects. Works collaboratively with clinical team to develop and meet timelines for project deliverables.
  • Establishes and maintains standards while implementing and championing organization standards.
  • May contribute to the assessment and preparation of in-licensing opportunities.
  • Supports the Company in establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.

Qualifications

  • PhD in Biostatistics or Statistics.
  • At least1 year of relevant experience in the Biotechnology/Pharmaceutical industry. Two to four years’ of experience for the senior Biostatistician .
  • Strong knowledge and expertise in statistical theory and its applications to clinical trials.
  • Knowledge of Good Clinical Practices and HA guidelines.
  • Sufficient skills of programming using statistical software packages such as SAS (and R).
  • Excellent verbal and written communication skills and interpersonal skills.
  • Strong leadership and project management skills.

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